Standard

SN EN ISO 11137-2:2007

Sep 2007 Withdrawn

Note: Latest version: SN EN ISO 11137-2:2015

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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009); Corrigendum AC Withdrawn SN EN ISO 11137-2/AC:2009 Corrigendum from Publication date: Sep 2009 Version: Pages: 1 Language: English, French, German Services: Online, Online + Pdf

Abstract

ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

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Standard from INB
Published: September 1 2007
Withdrawn: July 1 2012
Effective: September 1 2007
Document type: EN
Pages
ISBN:

ICS: 11.080.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171

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Replaced by: SN EN ISO 11137-2:2012
Replaces: SN EN ISO 11137-2:2006
Adopted from: ISO 11137-2:2006, IDT

SN EN ISO 11137-2:2007

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SN EN ISO 11137-2:2015

SN EN ISO 11137-2:2013

SN EN ISO 11137-2:2012